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Quality Manager

Top Prospect Group LLC

Trumbull, CT

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JOB DETAILS
SALARY
$100,000–$130,000 Per Year
SKILLS
Advanced Product Quality Planning (APQP), American Society for Quality (ASQ), CMM Inspection, Calibration, Capability Maturity Model (CMM), Certified Quality Engineer (CQE), Change Requests/Orders, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Detail Oriented, Documentation Plan, Engineering, Engineering Drawing, Engineering Management, Failure Mode and Effects Analysis (FMEA), Geometric Dimensioning and Tolerancing, ISO (International Organization for Standardization), ISO 9001, Laboratory Equipment, Leadership, Lean Manufacturing, Machining, Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Equipment, Mentoring, Metrology, Minitab, Problem Solving Skills, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Production Part Approval Process (PPAP), Prototyping, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Quality Metrics, Root Cause Analysis, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistics Software, Supply Chain Operations, Validation Documentation, Vendor/Supplier Evaluation
LOCATION
Trumbull, CT
POSTED
1 day ago
Job Title: Quality Manager
 Location: Trumbull CT
 Pay Rate: Based on Experience (Flexible for Top Candidates) 100,000 to 130,000
 Type: Direct Hire
 Schedule: 1st Shift
Overview
We are seeking a hands-on Quality Manager to join a growing Medical Device manufacturing company in Shelton, CT. This leadership role will oversee the Quality Assurance, Quality Control, and Metrology functions while ensuring compliance with ISO 9001:2015 and ISO 13485:2016 standards.
The ideal candidate will come from a Medical Device, Precision Manufacturing, Machining, or Stamping environment and have strong experience leading quality systems, audits, CAPA activities, inspections, validations, and continuous improvement initiatives in a fast-paced manufacturing setting.
Key Responsibilities
  • Lead and manage the Quality Department including Quality Engineers, QC Inspectors, and Metrology personnel 
  • Oversee daily Quality Assurance and Quality Control activities across manufacturing operations 
  • Ensure compliance with ISO 9001:2015 and ISO 13485:2016 standards 
  • Manage internal, customer, supplier, and third-party audits 
  • Lead CAPA investigations, root cause analysis, corrective and preventive actions 
  • Oversee calibration systems, metrology labs, and inspection equipment compliance 
  • Support APQP, PPAP, pFMEA, Gage R&R, capability studies, and First Article Inspections 
  • Manage CMM and VMM inspection programming activities 
  • Review and approve quality documentation, control plans, SOPs, validation documents, and work instructions 
  • Partner closely with Engineering, Manufacturing, Operations, and Supply Chain teams to improve product quality and manufacturing performance 
  • Support prototype inspections, validations, supplier approvals, and Supplier Change Requests (SCRs) 
  • Drive continuous improvement and Lean Manufacturing initiatives throughout the facility 
  • Analyze quality data and metrics using statistical tools and implement corrective actions as needed 
  • Serve as the primary quality contact for customer quality concerns, complaints, and audit activities 
  • Train, mentor, and develop Quality team members while promoting a strong quality culture throughout the organization 
Qualifications
  • Bachelor’s Degree in Engineering, Quality, Manufacturing, or related technical field preferred 
  • 5+ years of Quality Management or Senior Quality Engineering experience within Medical Device or regulated manufacturing environments 
  • Strong understanding of: 
    • ISO 9001:2015 
    • ISO 13485:2016 
    • CAPA Systems 
    • Audits and Compliance 
    • Root Cause Analysis 
    • Calibration and Metrology 
    • Validation Processes 
  • Experience managing Quality Engineers, Inspectors, and/or Metrology personnel 
  • Strong mechanical inspection and manufacturing background within machining, stamping, or precision manufacturing environments 
  • Ability to read and interpret engineering drawings, GD&T, and specifications 
  • Strong leadership, communication, and problem-solving skills 
Preferred Qualifications
  • Medical Device manufacturing experience strongly preferred 
  • Experience with Keyence Measurement Systems 
  • CMM / VMM programming experience 
  • Experience with Minitab statistical analysis software 
  • Knowledge of APQP, PPAP, FMEA, SPC, and Gage R&R methodologies 
  • Lean Manufacturing and Continuous Improvement experience 
  • ASQ Certifications (CQE, CQM, etc.) are a plus 
Work Environment
Fast-paced Medical Device manufacturing environment focused on quality, compliance, precision, and continuous improvement. This role requires strong leadership, attention to detail, and the ability to balance hands-on quality support with strategic quality management responsibilities.
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About the Company

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Top Prospect Group LLC

Top Prospect Group founders and management team offer more than 75 years of combined experience in Information Technology, Creative & Marketing, and Finance & Accounting staffing and solutions. Our fundamental goal is to build successful relationships resulting in accurate job and prospect representations. We meet with those we work with face-to-face to garner a better understanding of candidate or client requirements. By leveraging our experience and market insight, we are able to provide a more consistent recruitment process. Motivated by a partnership philosophy, our staff possesses a deep understanding of how to forge mutually beneficial long-term relationships. We believe in what we do and continuously strive for excellence.

COMPANY SIZE
20 to 49 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2009
WEBSITE
http://www.topprospectgroup.com/

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